By David Kiefer, MD
Clinical Assistant Professor, Department of Family Medicine, University of Wisconsin; Clinical Assistant Professor, Arizona Center for Integrative Medicine, University of Arizona, Tucson
Dr. Kiefer reports he is a consultant for WebMD.
SYNOPSIS: Both real and sham acupuncture provide benefits for women suffering from menopausal hot flashes, including for months after the treatment ends.
SOURCE: Ee C, et al. Acupuncture for menopausal hot flashes: A randomized trial. Ann Intern Med 2016;164:146-154. doi:10.7326/M15-1380.
SUMMARY POINTS
- Menopausal vasomotor symptoms respond to 8 weeks of either real or sham acupuncture treatments.
- Benefits are seen in number and severity of hot flashes, quality of life, and anxiety/depression, and these benefits persist even for 6 months after the acupuncture treatments end.
- Real acupuncture causes a greater number of mild side effects, such as pain and bruising, than does sham acupuncture.
Menopausal vasomotor symptoms, including hot flashes and night sweats, are often imperfectly treated by conventional and integrative therapies, and the data for acupuncture are mixed, rife with methodological flaws and small sample sizes. The authors of this trial pointed to only one prior acupuncture study with a sham, or nonfunctional, acupuncture arm. Hence, their justification to expand the literature on this topic.
This is a randomized, blinded (except for acupuncturists), parallel, sham-controlled trial. Women were included if they were postmenopausal or in late menopausal transition (> 12 months without menstruation, or elevated follicle stimulating hormone plus vasomotor symptoms plus > 2 months amenorrheic, respectively). Also, the trial included women with a hot flash score of at least 14 (see Figure 1), or who had kidney yin deficiency. Kidney yin deficiency, per the authors, is common in women who are postmenopausal and have symptoms; this diagnosis was determined by experienced acupuncturists via history, and tongue and pulse examination. There were extensive exclusion criteria, the most likely of which to affect a typical clinical practice were any acupuncture within the prior 2 years, medical reasons for amenorrhea, uncontrolled thyroid disease, hormone replacement therapy or vaginal estrogen therapy, or vasomotor treatment in the prior 3 months.
FIGURE 1: CALCULATION OF HOT FLASH SCORE |
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Hot Flash Score = (number of mild hot flashes x 1) + (number of moderate hot flashes x 2) + (number of severe hot flashes x 3) + (number of very severe hot flashes x 4) |
The acupuncture treatment was a standardized protocol, based on Chinese acupuncture to treat kidney yin deficiency as extrapolated from effective treatments described in a reputable textbook, medical literature, and clinical trials, and from three experts’ commentaries. Treatments were for 20 minutes, and were administered twice weekly for 2 weeks, then weekly for 6 weeks (a total of 8 weeks). Sham acupuncture used a device that replicated the visual and physical sensation of receiving acupuncture without any needle insertion. The researchers cited literature that differentiates the clinical effect of sham vs true acupuncture and supports this methodology. There was no placebo group.
The primary outcome was the number and severity of hot flashes at the end of 8 weeks. Study participants recorded numbers of mild, moderate, severe, and very severe hot flashes. A hot flash score was calculated as delineated in Figure 1. Table 1 displays the information collected at different time points of the study, and included the above-mentioned hot flash diary, as well as the Menopause-Specific Quality of Life Questionnaire (MSQLQ) and the Hospital Anxiety and Depression Scale (HADS).
TABLE 1: DATA COLLECTED DURING AND AFTER THE ACUPUNCTURE STUDY |
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Time |
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Baseline |
4 weeks |
8 weeks (end of trial) |
3 months after trial |
6 months after trial |
|
Demographics |
||||
|
Hot flash diary |
Hot flash diary |
Hot flash diary |
Hot flash diary |
Hot flash diary |
|
MSQLQ |
MSQLQ |
MSQLQ |
MSQLQ |
MSQLQ |
|
HADS |
HADS |
HADS |
HADS |
HADS |
|
Inquiry about other hot flash treatments |
Inquiry about other hot flash treatments |
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MSQLQ = Menopause-Specific Quality of Life Questionnaire; HADS = Hospital Anxiety and Depression Scale |
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The researchers screened 2140 women and, after exclusions and participation declinations, an acupuncturist examined 347 patients, 338 of whom had kidney yin deficiency, and 327 were then randomly assigned (163 to acupuncture, 164 to sham acupuncture). At the end of treatment, 16% of women in the acupuncture group and 13% in the sham acupuncture group were lost to follow-up. A total of 279 women had data included from the end of the trial, though some of these data were incomplete; for example, 46 women did not complete all acupuncture (real or sham) treatments. Researchers provided detailed information about dropouts and missing data. Women who were lost to follow-up or dropped out underwent an intention-to-treat analysis.
The mean age of the study participants was 55 years, and baseline characteristic analyses were similar between treatment and sham groups, except for the fact that women in the sham acupuncture group had more prior experience with acupuncture (78% vs 64%). Overall, both the sham and true acupuncture groups showed improvements in hot flash score, frequency, and severity, and in the MSQLQ and HADS from baseline to 4 and 8 weeks. These results approximated a 40% improvement, and were sustained to 3 and 6 months post-trial. There were no statistically significant differences in any of the time points group-by-group.
No serious adverse events were reported in the trial, although the acupuncture group had more mild-moderate events (21 vs 5), such as pain or bleeding/bruising, that the researchers ascribed as being “intrinsic” to acupuncture and not of concern.
COMMENTARY
This is not the first randomized, controlled trial exploring the use of acupuncture for menopausal hot flashes, nor is it the only integrative therapeutic studied for this condition. Given the less-than-convincing efficacy (and safety) of conventional treatments, many of our patients with hot flashes continue to suffer, necessitating a search for viable options. We have reviewed other trials for acupuncture and hot flashes,1 and surely will do so again until the research refines itself. The methodology of this trial is impressive, and had the possibility of providing definitive proof of the utility of acupuncture for this condition. Except for the fact that, in this case, acupuncture didn’t work.
Where did it all go wrong? Acupuncture should have shown efficacy in this trial. It has a plausible mechanism, and the researchers cited research showing that acupuncture might affect monoamines, which are relevant to the development of hot flashes. In addition, this trial was well-organized, adequately powered, and grounded in traditional Chinese medicine diagnosis and treatment. The large numbers of dropouts and participants lost to follow-up are certainly implicated in the interpretation of the final results, although the researchers analyzed the data in many different ways to factor in these effects, failing to find clinically relevant information in missing vs non-missing data.
Another factor possibly accounting for a lack of acupuncture effect is that sham does not equal placebo; the device, considered “…the best available sham acupuncture method at the time of study design…,” still provides a needle prick sensation with only “minor” physiological effects. This phenomenon catapults us into the philosophical stratosphere of the meaning behind placebos and whether it is possible to have a non-functioning placebo to which other treatments are compared, or even whether it matters; in clinic, we want the placebo (the positive placebo) to be involved in healing. In the case of hot flashes, researchers have an uphill battle due to a disproportionately high placebo effect that is difficult to outperform with any particular treatment. Maybe there is an effect with acupuncture, but we just can’t see it.
Perhaps, clinicians should just fall in line with Cochrane2; acupuncture works for hot flashes when compared to no treatment at all, but not when compared to sham acupuncture. So, please do something for your patients with hot flashes, rather than nothing at all (as we all know, avoid “Sorry, there’s nothing I can do for you.”). At least we know, from this study and others, that we can provide relief to our patients with menopausal hot flashes, until a better comparative treatment (adequate sham) is being worked out by researchers to tell us whether that relief comes from “true” acupuncture or something close to it.
REFERENCES
- Haas W. Electroacupuncture for hot flashes among breast cancer survivors. Integrative Medicine Alert 2015;18:121-123.
- Dodin S, et al. Acupuncture for menopausal hot flushes. Cochrane Database Syst Rev 2013;7:CD007410. doi:10.1002/14651858. CD007410.pub2.
Both real and sham acupuncture provide benefits for women suffering from menopausal hot flashes, including for months after the treatment ends.
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